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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 March 2015 |
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Main ID: |
NCT02394041 |
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Date of registration:
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16/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomised Controlled Trial of the Efficacy of Acupuncture Versus Placebo on the Caesarean Section Rate in Case of Cervical Dystocia in Full-term Pregnancy
ACUCESAR |
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Scientific title:
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A Randomised Controlled Multicenter Trial Evaluating the Efficacy of Acupuncture Versus Placebo on the Caesarean Section Rate in Case of Cervical Dystocia in Full-term Pregnancy |
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Date of first enrolment:
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November 2012 |
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Target sample size:
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142 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT02394041 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Denis COLIN, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Obstetrics, Hôpital Saint-Cloud |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aged = 18 years
- Signed informed consent
- Woman carrying one foetus only
- at 37 weeks (+/- 2 days) of amenorrhea
- Without contraindication to vaginal delivery
Exclusion Criteria:
- Prior history of caesarean section
- Non-cephalic presentation
- Fetal macrosomia
- Multiple pregnancy
- Chronic fetal hypoxia
- Placenta praevia
- Risk of neonatal contamination
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cervical Dystocia
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Intervention(s)
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Device: Acupuncture
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Device: Sham acupuncture
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Primary Outcome(s)
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Caesarean section rate
[Time Frame: up to 37 weeks]
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Secondary ID(s)
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P081233
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AOM09091
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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